Manufacturing Inspection Readiness Manager - Ireland
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- Our company is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases.
- We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children.
- These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options.
- Our company will continue to focus on advancing therapies that are the first or best of their kind.
- Our company’s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain our company’s cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients. Come join our team and make a meaningful impact on patients’ lives.
- Our company is a high-performing, team based organization, where colleagues are flexible, multi-skilled and empowered to make decisions.
- A high level of initiative, energy and motivation are key role requirements, as well as excellent organizational skills.
- The Manufacturing Inspection Readiness Manager is responsible for supporting GMP compliance within the manufacturing department.
- The initial focus of the role is to set-up an internal compliance programme encompassing self-inspection, management of executed documents (Batch records, logbooks and SOP’s) and defining metrics and reporting systems for highlighting issues and an escalation process for same.
- In addition the role will include the investigation and co-ordination of deviations, CAPA’s, change controls and procedural updates and the overall tracking and reporting of their status. An expertise in Trackwise is essential.
- The Manufacturing Inspection Readiness Manager will co-ordinate and organise product change-over activities, and support the general GMP needs of the manufacturing floor staff by being an available GMP resource for all manufacturing colleagues.
- This position involves interaction with cross-functional departments and fostering a close relationship with Quality.
- Key factors in the function of this position are flexibility, good organizational skills, excellent time management, accountable for self and others, and being self-motivated with a continuous improvement mindset.
- Set-up an internal Compliance Programme within the manufacturing department.
- Self-Inspection Programme
- Management of GMP Records
- Tracking and Reporting Systems
- Escalation process
- Lead and co-ordinate inspection preparation activities.
- Accountable for training oversight of all manufacturing colleagues.
- Generate responses to audit findings.
- Full understanding of basic cGMP expectations; set a lead example in observance of cGMP policies.
- Interact regularly with Manufacturing colleagues to answer questions related to GMPs and help champion a compliant work environment with a Continuous Improvement Focus
- Work with the TOPS Support team to evaluate and implement local/global CAPAs, regulatory/audit recommendations & general improvement projects.
- Report on the timeliness of compliance to set timelines on Deviations, Quality Events, Material Incidents, CAPAs, and Effectiveness Checks in Trackwise
- Managing Change Requests (CRs)
- Work with Manufacturing staff and QA Change Control to contribute to comprehensive implementation plans for CRs
- Product Change-Over
- Work with manufacturing colleagues to coordinate and organize product change-over activities and recommend future improvements.
- Acquire fundamental knowledge of technical aspects of Media/Buffer Prep, Cell Culture and Purification operations
- Comply with cGMP Documentation & Operations
- Compliance with safety guidelines
The Manufacturing Inspection Readiness Manager works within manufacturing to ensure that the manufacturing department has a robust compliance programme with a well-defined tracking and reporting process to ensure GMP compliance and audit readiness.
BA or BS in a technical discipline (physical or biological sciences preferred but not required) with 5+ years related to pharmaceutical manufacturing
- 10+ years’ experience in a GMP regulated environment, with exhibited knowledge or proficiency in a compliance or quality role.
- Experience leading and implementing projects
- Demonstrated ability to influence peers and teams.
- Ability to speak, present data, and defend approaches in front of a variety of audiences.
- Organizational skills to contribute to department & cross-functional projects
- Familiarity with FDA & European GMP’s and regulatory requirements, guidelines, and recommendations.
- Strong proficiency with Trackwise
- Technical writing must be at a high level with proficient spelling, grammar, and typing skills preferred.
- Proficiency with standard office software applications, including MS Word, MS Excel, MS Project, MS Power Point. Experience and proficiency with other applications.
- This function will perform majority of work in an office setting, reviewing documents, participating in meetings, authoring documents. This function may perform up to 50% of its functions at a computer terminal.
- The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- While performing the duties of this job, the employee is occasionally exposed to work near moving mechanical parts; fumes or airborne particles; toxic or caustic chemicals; high pressure and temperature utility systems, risk of electrical shock and vibration. The noise level in the work environment is usually moderate.
- The employee may frequently be required to sit and talk or hear.
- The employee is occasionally required to stand; walk; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl and taste or smell. The employee must occasionally lift and/or move up to 25 pounds.
- Specific vision abilities by this job include close vision, depth perception and ability to adjust focus.
- This position requires ability to utilize a computer to perform tasks, including report generation.
- Ability to perform gown activities and enter the manufacturing plant is required.
- Other projects may include working with Benchtop analytical instruments, filter integrity testers, process tanks, Autoclaves, Labwashers, Bioreactor systems, Chromatography columns and controlling skids.
This position will require interaction with multiple levels (from employees up to Management) in Quality Assurance, Quality Control, Corporate Compliance, Manufacturing, Manufacturing Sciences, Facilities and Purchasing. Position will also interact with technical and sales vendor representatives.
- This Manufacturing Inspection Readiness Manager position will have a number of direct reports including a Compliance Specialist, Training and technical Writing responsibilities. The role is expected to grow with increased Manufacturing operations onsite. In addition, this position will provide coaching and influencing of all Manufacturing staff.
- Demonstrated proficiency and experience in project work within cGMP expectations for the manufacture of drugs at our company.
- Successfully achieving project goals and meeting company deadlines in timely and cost-effective manner.
- Demonstrated experience and knowledge of multi-departmental functions and issues (understanding the organization).